NCT00389532

Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To submit remaining available sera to Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)	Influenza vaccine
BIOLOGICAL	Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)	Influenza vaccine

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-04-01
• Completion: 2008-09-01
• First posted: 2006-10-19
• Last updated: 2016-04-14
• Results posted: 2009-03-30

Locations

1 site across 1 country: United States